Drugs

Sun’s JAK Inhibitor OK’d for Alopecia Areata

FDA has approved a Sun Pharmaceutical Industries NDA for Leqselvi (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata, a common autoimmune disease in which hair loss is thought to occur due to the collapse of “immune privilege,” according to the company. This collapse leads to the immune system targeting the hair follicles and causing sudden hair loss on the scalp, face and sometimes other areas of the body, it says.

Leqselvi is described as a new, twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. The JAK inhibitor is designed to interrupt the pathways thought to contribute to hair loss in severe alopecia areata, Sun says.

Approval is based on data from two randomized, double-blind, placebo-controlled Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with alopecia areata who had at least 50% scalp hair loss as measured by Severity of Alopecia Tool for more than six months. “The number of patients taking LEQSELVI and achieving a SALT score of less than 20 showed a consistent upward trend with no plateau through 24 weeks,” the company says. “Additionally, up to 25% of patients had almost all of their scalp hair back at 24 weeks (greater than 90% coverage).”

Regarding safety, Sun says Leqselvi may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. “There also may be an increased risk of mortality and major cardiovascular events,” it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome